1. Field of the Invention
The invention concerns a procedure for the manufacture and/or handling of a substantially pure object, in particular a medical container, for example, a prefillable container for the reception of drugs. Furthermore, the invention concerns a corresponding device for the handling of such a substantially pure object.
2. Description of the Related Art
There are medical containers known, which are used for the storing of medicinal and pharmaceutical substances. In particular, such containers are prefillable containers such as, for example, prefillable bottles or prefillable syringes made from glass or plastic, which are delivered, prefilled with a drug.
These types of container for the storage of medicaments and pharmaceutics have to essentially satisfy two aspects, namely to protect the substance to be stored from changes and to also keep the contents of the container free from impurities. The official minimum requirements for this are, for example, described in the Pharmacopoeia and consequently conclusively stipulated. In detail, the demands on products may go far beyond these.
Potential impurities such as particles or microbes may not only get into the container from the environment, but more often than not they may also originate from the container itself, that is to say, for example, either during or through the molding or production process of the container. As a result the relevant regulations stipulate the highest values for permissible particulate and endotoxin loads.
In particular, contamination of a plastic article may occur when following the manufacturing and ejection process, the plastic article exhibits an electrostatic charge, which attracts particles from the environment and prevents the attached particles from being rinsed off. Therefore, in the customary manufacturing process a procedure is used in order to discharge the plastic parts after ejection. At the same time, however, the discharging is often incomplete and recharging effects occur, through which charges from the inside of the plastic parts reach the surfaces over a longer period of time.
Usually particulate and endotoxin loads are prevented through the washing of the container after molding and before filling, as is described in U.S. Pat. No. 4,718,463. What is more, pyrogens are generally removed from these containers through the application of high temperatures up to 300° Celsius. This application of high temperatures may, however, only be used for glass containers since generally speaking, plastic containers would be destroyed at these temperatures.
Therefore, other procedures are used for the manufacture and cleaning of plastic containers. U.S. Pat. No. 5,620,425 describes the manufacture of a prefillable syringe cylinder in a Class 100 clean room, which ought to prevent impurities during the manufacture of the syringe body. However, the complete production of a syringe body or of a syringe in a clean room is only possible at great expense. A Class 100 clean room atmosphere is only possible with the creation of a laminar flow, which can only be maintained with a high level of difficulty, especially when personnel are working in the clean room and an injection molding machine, requiring the opening and closing of mold platens, is used. Therefore the conditions described in U.S. Pat. No. 5,620,425 during the manufacture of a plastic syringe in injection molding are not able to be maintained at all or only with great difficulty, in order to achieve the required sterility. In addition to this the clean room conditions and their suitability for the respective product first have to be validated regarding cost and then have to be intensively monitored during operation. Overall the running of this type of clean room thus presents a considerable expense, which leads to a considerable increase in the cost of the manufactured product.
Therefore, U.S. Pat. Nos. 6,164,044, 6,189,292, 6,263,641 and 6,250,052 describe a further manufacturing procedure for the manufacture of prefillable glass or plastic containers. In accordance with the procedures described in these patents, the containers or the syringe cylinders are put into a closed system following their production by the pouring or forming of the glass or the injection molding of the plastics for further processing. This system consists of individual containers or cabinets in which a clean room atmosphere prevails. When the containers manufactured outside of this clean room atmosphere are brought into the closed system they are first cleaned by a current of purified air so that any particles or germs potentially attached to the containers are rinsed off or sprayed away from the containers. The containers cleaned in this way are subsequently further processed in the system in which Class 100 clean room conditions prevail.
Even this arrangement has the disadvantage that Class 100 clean room conditions have to be achieved for all of the handling and for the filling into the closed cabinets or containers. Furthermore, there is the danger that microbes or particles are attached to the containers manufactured outside of the clean room system despite the initial cleaning.
Therefore, there is a need for a new system, device and method for manufacturing and/or handling a substantially pure object, such as a medical container, which allows for more cost effective and more simple production and which simultaneously is able to guarantee a greater purity. In particular, an efficient procedure for the manufacture of medical containers that satisfies and/or exceeds the requirements of the Pharmacopoeia with regard to cleanliness, in particular with regard to particles and/or endotoxins, is desirable. Further, a system, device or method that can avoid the expense and complexity of very sterile clean rooms, in particular those of Class 100, and the need for air or water washing of the container after molding, is particularly desirable.